BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZZZ-PAP

    MDR report key: 1545568 · Received November 19, 2009

    Report

    Report Number
    MW5013650
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    October 29, 2009
    Report Date
    November 19, 2009
    Manufacturer
    PROBASICS BY PMI
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND IS DIAGNOSED WITH SLEEP APNEA AND USES A CPAP MACHINE. THE MACHINE IN QUESTION HAS BEEN IN USE ABOUT 2 YEARS. IT IS IDENTIFIED AS FOLLOWS: PROBASICS ZZZ-PAP WITH INTEGRATED HEATED HUMIDIFIER, MODEL# 9S-006000 SERIES, ITEM# 7600. AT 2:50 AM IN 2009, I AWOKE TO THE SMELL OF SOMETHING BURNING. THE SOURCE WAS IDENTIFIED AS THE HEATER ELEMENT OF THE ABOVE DEVICE. THE PLASTIC HAD COMPLETELY MELTED BELOW THE HEATER ELEMENT AND HAD CHARRED THE TABLE IT WAS SITTING ON. WE BELIEVE THAT WE WERE ONLY A VERY SHORT TIME FROM A CATASTROPHIC FIRE EVENT. WE WERE CONCERNED ABOUT REPORTING THIS EVENT, AS THERE CLEARLY IS A DANGER. WE TRIED CONTACTING THE MFR, BUT THE PERSON ANSWERING THE PHONE WAS ADAMANT THAT THEY WOULD NOT TAKE A COMPLAINT OR REPORT OF THIS NATURE - THAT WE SHOULD CONTACT THE SELLER OF THE DEVICE. WE DID NOT BELIEVE THAT THE SELLER WAS THE ONE TO BE NOTIFIED, THAT THE MFR SHOULD BE THE ONE CONCERNED. SHE FINALLY CONNECTED US TO THE VOICEMAIL OF A PERSON IDENTIFIED AS "IN CHARGE." WE HAVE NEVER HEARD FROM PROBASICS. WE HAVE TRIED CONTACTING VARIOUS GOVERNMENT ENTITIES TO IDENTIFY WHO WOULD BE INTERESTED IN RECEIVING THE INFO ON THIS DANGEROUS DEVICE. NO ONE SEEMS TO BE "IN CHARGE." IS THIS THE CORRECT AGENCY?. DATES OF USE: 2 YEARS. DIAGNOSIS: SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZZZ-PAP CPAP BZD PROBASICS BY PMI 9S-006000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening